PCSK9 inhibitors in clinical practice: Novel directions and new experiences

Rallidis, Lοukianos S.; Skoumas, Ioannis; Liberopoulos, Evangelos; Vlachopoulos, Charalambos; Kiouri, E.; Koutagiar, Iosif; Anastasiou, Georgia; Kosmas, Nikolaos; Elisaf, Moses; Tousoulis, Dimitrios; Iliodromitis, Efstathios K.

doi:10.1016/j.hjc.2019.10.003

Cited by 17 publications

(24 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The patients with statin intolerance who were treated with PCSK9 inhibitor monotherapy achieved their LDL-C reduction goals from baseline levels without adverse effects. Combined treatment with statin, ezetimibe, and PCSK9 inhibitors have a greater effect in reducing LDL-C ( P = 0.037) compared with PCSK9 inhibitors alone, as previously reported in Gamera-Boers et al and Rallidis LS et al [ 15 , 18 ].…”

Section: Discussionsupporting

confidence: 79%

See 1 more Smart Citation

PCSK-9 Inhibitors in a Real-World Setting and a Comparison Between Alirocumab and Evolocumab in Heterozygous FH Patients

Ceballos-Macías¹,

Lara-Sánchez²,

Flores-Real

et al. 2020

Journal of the Endocrine Society

View full text Add to dashboard Cite

A real-world setting study of Familial hypercholesterolemia (FH) patients which received PCSK9 inhibitors in a specialized referral center in Mexico City. Ten patients between the age of 18-70 years and a diagnosis of FH according to DLCN criteria with failure to achieve LDL-C goals with standard therapy between 2016 and 2017 enrolled in a simple randomization in which a group of five participants received alirocumab (75 mg every two weeks) and the remaining five patients evolocumab (140 mg every two weeks). Comparative analysis was made analyzing the means of LDL at the baseline, at 4, 6, and 12 weeks. The evolocumab group had an average initial LDL-C of 277 mg/dL which, after 12 weeks of treatment, was significantly reduced to 116 mg/dL; p= 0.04 (IC95 11.5-310.9). The alirocumab group with a mean initial LDL-C of 229 mg/dL showed a reduction at 12 weeks of treatment to 80 mg/dL; p= 0.008 (IC95 63.8-233.7). In conclusion, PCSK9 inhibitors are an excellent treatment option in patients with FH who do not reach LDL-C goals with standard therapy or due to intolerance. There is no difference in the lipid-lowering effect between both PSCK9 inhibitors.

show abstract

Section: Discussionsupporting

confidence: 79%

“…Of the patients analyzed, 39.8% did not continue treatment after 60 days because it required authorization and periodic evaluation in order to continue with PCSK9 inhibitor treatment [ 17 ]. The percentage of suspension or nonadherence to treatment was higher than that reported in other studies (between 8% and 10%) [ 15 , 18 ].…”

Section: Discussioncontrasting

confidence: 69%

PCSK-9 Inhibitors in a Real-World Setting and a Comparison Between Alirocumab and Evolocumab in Heterozygous FH Patients

Ceballos-Macías¹,

Lara-Sánchez²,

Flores-Real

et al. 2020

Journal of the Endocrine Society

View full text Add to dashboard Cite

show abstract

“…Of interest, in our study the percentage of LDL-C goal attainment was 81%. This proportion is higher than other cohorts reporting LDL-C target achievement by 55-76% 20,22,24,26,29 .…”

Section: Discussioncontrasting

confidence: 57%

PCSK9 inhibitors: The breakthrough lipid-lowering treatment at real-life setting – A 2-year regional lipid clinic experience

Anastasiou¹,

Liamis²,

Milionis³

et al. 2020

JAPT

Self Cite

View full text Add to dashboard Cite

Aim: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been demonstrated to be safe and effective in low-density lipoprotein cholesterol (LDL-C) lowering and cardiovascular risk reduction. Data on clinical implementation of PCSK9 inhibitors in real life setting in Greece is limited. Thus, we report 2-year experience with PCSK9 inhibitors in clinical practice at a University Hospital Lipid Clinic. Patients and methods: This is a retrospective study of patients who were first prescribed a PCSK9 inhibitor during 2016-2018. Patients had either established cardiovascular disease (CVD) and/or familial hypercholesterolemia (FH) and LDL-C level >100 mg/dL despite maximum tolerated high-intensity statin plus ezetimibe. Patient demographics, medical history, concomitant medications and laboratory results were documented during visits. Results: We included 37 patients (mean age 52 years, 56.8% males). Of patients, 28 (76%) had established CVD and 27 patients (74%) had FH. Concerning treatment, 33 patients (89%) were receiving high-intensity statin, while 35 patients (95%) were also on ezetimibe 10 mg. Addition of PCSK9 inhibitors (51% on evolocumab 140 mg per 2 weeks (Q2W), 22% on alirocumab 75 mg Q2W and 27% on alirocumab 150 mg Q2W) resulted in a reduction of total cholesterol by 42% and LDL-C by 59% after 2 months (p<0.05). These reductions remained unchanged after 1 and 2 years on treatment. Thirty patients (81%) achieved LDL-C treatment goal following PCSK9i treatment. Four patients (11%) developed minor adverse effects. No treatment discontinuation was reported. Conclusion: In real-life setting addition of PCSK9 inhibitors to maximally tolerated lipid-lowering therapy resulted in reductions of LDL-C levels of the magnitude seen in clinical studies. These reductions were sustainable during a 2-year follow-up.

show abstract

“…The 2019 ESC guidelines [ 4 ] and Ridker et al [ 17 ] have endorsed a constant PCSK9i efficacy, regardless of the background therapy. Rallidis et al [ 27 ] reported a potent effect of PCSK9i on top of the statin in LDL-c reduction compared to those receiving PCSK9i monotherapy. By reducing the intracellular hepatic cholesterol, statin subsequently activates the sterol regulatory element binding protein transcription factor, increases not only the LDLR expression but also the PCSK9 expression, and consequently the circulating PCSK9 protein [ 5 ].…”

Section: Discussionmentioning

confidence: 99%

Real-World Efficacy of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors (PCSK9i) in Heterozygous Familial Hypercholesterolemia Patients Referred for Lipoprotein Apheresis

et al. 2021

View full text Add to dashboard Cite

Background A small proportion of familial hypercholesterolemia (FH) patients can adequately control this condition, although achieving the recommended targets for low-density lipoprotein cholesterol (LDL-c) levels remains a challenge. Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are new and potent lipid-lowering drugs. However, there is scarce literature on real-world data about their use in patients with FH. Material/Methods We examined the reduction in LDL-c levels from the baseline, after PCSK9i initiation in heterozygous familial hypercholesterolemia patients referred for lipoprotein apheresis in our regional lipid clinic. The study was conducted from March 2018 to September 2019, the period immediately after PCSK9i reimbursement was available in France. PCSK9i was added on top of the patients’ maximal tolerated lipid-lowering regimens. Results The study had 123 patients with heterozygous FH. The mean age of the patients was 59±11 years. The mean baseline LDL-c for all the participants was 277±78 mg/dl. It was 283±81 mg/dl in the PCSK9i monotherapy group (n=83), 247±68 mg/dl in the PCSK9i plus ezetimibe group (n=12), and 264±78 mg/dl in the PCSK9i plus statin and ezetimibe group (n=28). The mean decrease observed in the LDL-c level from baseline was 136±70 mg/dl (n=123), 125±60 mg/dl (n=83), 103±77 mg/dl (n=12), and 175±70 mg/dl (n=28), respectively. Conclusions An overall reduction of 49.1% from the baseline LDL-c was observed in the heterozygous FH population after PCSK9i initiation in a real-world experience. The group treated with PCSK9i ezetimibe plus statin showed further reduction of their LDL-c levels with a better responder rate, achieving the target 50% reduction in LDL-c from the baseline.

show abstract

PCSK9 inhibitors in clinical practice: Novel directions and new experiences

Cited by 17 publications

References 23 publications

PCSK-9 Inhibitors in a Real-World Setting and a Comparison Between Alirocumab and Evolocumab in Heterozygous FH Patients

PCSK-9 Inhibitors in a Real-World Setting and a Comparison Between Alirocumab and Evolocumab in Heterozygous FH Patients

PCSK9 inhibitors: The breakthrough lipid-lowering treatment at real-life setting – A 2-year regional lipid clinic experience

Real-World Efficacy of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors (PCSK9i) in Heterozygous Familial Hypercholesterolemia Patients Referred for Lipoprotein Apheresis

Contact Info

Product

Resources

About